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FDA 510(k)

THIXO-GEL ULTRASOUND SPRAY

K-Number: K121311 · 2012-08-30

ApplicantCloverline International Pharma Services GmbH
Decision Date2012-08-30
Product CodeMUI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

THIXO-GEL ULTRASOUND SPRAY is the device name listed in this FDA 510(k) record. The listed applicant is Cloverline International Pharma Services GmbH. It received FDA 510(k) clearance on 2012-08-30 under 510(k) number K121311. The device is classified under product code MUI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THIXO-GEL ULTRASOUND SPRAY?

THIXO-GEL ULTRASOUND SPRAY is a medical device that received FDA 510(k) clearance on 2012-08-30. The listed applicant is Cloverline International Pharma Services GmbH. The 510(k) number is K121311.

When did THIXO-GEL ULTRASOUND SPRAY receive FDA 510(k) clearance?

THIXO-GEL ULTRASOUND SPRAY received FDA 510(k) clearance on 2012-08-30, under 510(k) number K121311.

Who is the listed applicant for THIXO-GEL ULTRASOUND SPRAY?

The FDA 510(k) record lists Cloverline International Pharma Services GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THIXO-GEL ULTRASOUND SPRAY?

The FDA product code for THIXO-GEL ULTRASOUND SPRAY is MUI.

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Related Devices (Code: MUI)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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